Trial Outcomes & Findings for Oral ONC201 in Adult Recurrent Glioblastoma (NCT NCT02525692)
NCT ID: NCT02525692
Last Updated: 2024-12-24
Results Overview
Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Progression-free survival assessments were conducted 6 months following treatment initiation.
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Arm A
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
8
|
30
|
3
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
8
|
30
|
3
|
7
|
Reasons for withdrawal
| Measure |
Arm A
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
5
|
0
|
1
|
|
Overall Study
Death
|
16
|
18
|
7
|
20
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
5
|
0
|
0
|
Baseline Characteristics
Oral ONC201 in Adult Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Arm A
n=17 Participants
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
n=19 Participants
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
n=8 Participants
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
n=30 Participants
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
n=3 Participants
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
n=7 Participants
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
56.0 years
n=7 Participants
|
66.5 years
n=5 Participants
|
35.0 years
n=4 Participants
|
37.0 years
n=21 Participants
|
50.0 years
n=8 Participants
|
48.0 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
43 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
72 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Primary Tumor Location
Brainstem
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Primary Tumor Location
Midline ex-brainstem
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Primary Tumor Location
Non-midline
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Progression-free survival assessments were conducted 6 months following treatment initiation.Population: Note: In Arm B, one participant with recurrent H3 K27M-mutant glioblastoma and non-measurable disease experienced complete regression of enhancing lesions for \>1.5 years was censored from analysis due to use of anastrozole at baseline and throughout the study.
Progression-free survival rate at 6 months was defined as the percentage of patients who exhibit progression-free survival for \>6 months.
Outcome measures
| Measure |
Arm A
n=17 Participants
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
n=19 Participants
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
n=8 Participants
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
n=30 Participants
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
n=3 Participants
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
n=7 Participants
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
|---|---|---|---|---|---|---|
|
Percent of Patients With Probability of Progression-Free Survival at 6 Months
|
11.8 percentage of patients
Interval 2.0 to 31.2
|
0 percentage of patients
Not calculated due to insufficient number of participants with events.
|
NA percentage of patients
Not calculated. By design, all patients in this cohort had surgery shortly after initiation of dordaviprone (ONC201) with no preceding post-baseline assessment; hence, all patients are censored for PFS at baseline.
|
14.5 percentage of patients
Interval 4.6 to 29.8
|
0 percentage of patients
Not calculated due to insufficient number of participants with events.
|
14.3 percentage of patients
Interval 0.7 to 46.5
|
Adverse Events
Arm A
Serious events: 6 serious events
Other events: 16 other events
Deaths: 16 deaths
Arm B
Serious events: 1 serious events
Other events: 17 other events
Deaths: 18 deaths
Arm C
Serious events: 1 serious events
Other events: 5 other events
Deaths: 7 deaths
Arm D
Serious events: 11 serious events
Other events: 29 other events
Deaths: 20 deaths
Arm E
Serious events: 1 serious events
Other events: 2 other events
Deaths: 3 deaths
Arm F
Serious events: 1 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A
n=17 participants at risk
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
n=19 participants at risk
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
n=8 participants at risk
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
n=30 participants at risk
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
n=3 participants at risk
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
n=7 participants at risk
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
17.6%
3/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Disease progression
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Fatigue
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Gait disturbance
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Chest pain
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Troponin T increased
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor haemorrhage
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnoea
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
Other adverse events
| Measure |
Arm A
n=17 participants at risk
Patients with histologically confirmed WHO Grade IV glioblastoma with any number of recurrences.
Patients received 625 mg oral ONC201 once every 3 weeks.
|
Arm B
n=19 participants at risk
Patients with first recurrence of histologically confirmed WHO Grade IV glioma.
Patients received 625 mg oral ONC201 once every week (Days 1, 8, and 15 of each cycle).
|
Arm C
n=8 participants at risk
Patients with clinical and/or radiographic evidence of first recurrence of histologically confirmed WHO Grade IV glioblastoma and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm D
n=30 participants at risk
Patients with confirmed WHO Grade IV glioma with H3 K27M mutation (any number of recurrences were allowed).
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
Arm E
n=3 participants at risk
Patients with clinical and/or radiographic evidence of midline glioma (recurrent disease was not required) and were eligible for salvage surgical resection.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8 and 15 of each cycle). Surgical resection was performed approximately 24 hours after at least the second dose of ONC201.
|
Arm F
n=7 participants at risk
Patients with diffuse midline glioma involving the brainstem, thalamus, or spinal cord, without H3 K27M mutation or with unknown H3 mutation status.
Patients received 625 mg oral ONC201 once weekly (Days 1, 8, and 15 of each cycle).
|
|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
20.0%
6/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Cardiac disorders
Bradycardia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Cardiac disorders
Atrioventricular block
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Eye disorders
Diplopia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Eye disorders
Vision blurred
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Eye disorders
Dry eye
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Eye disorders
Photophobia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
5/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
15.8%
3/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
23.3%
7/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
57.1%
4/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
16.7%
5/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
15.8%
3/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
13.3%
4/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Fatigue
|
35.3%
6/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
21.1%
4/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
16.7%
5/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Gait disturbance
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
15.8%
3/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Oedema peripheral
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Asthenia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
General disorders
Disease progression
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
21.1%
4/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
13.3%
4/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Platelet count decreased
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
White blood cell count increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Blood glucose increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Blood phosphorus decreased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Neutrophil count increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Weight increased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
Blood magnesium decreased
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.6%
3/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
21.1%
4/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
13.3%
4/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
29.4%
5/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
16.7%
5/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
21.1%
4/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
26.3%
5/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
25.0%
2/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
26.7%
8/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hemiparesis
|
23.5%
4/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
23.3%
7/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Seizure
|
29.4%
5/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Aphasia
|
17.6%
3/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
15.8%
3/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
15.8%
3/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
13.3%
4/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Paraesthesia
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Dysarthria
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
12.5%
1/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Somnlolence
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Haemorrhage intracranial
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Apraxia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Aura
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Disturbance in attention
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Psychiatric disorders
Confusional state
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Psychiatric disorders
Insomnia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.5%
2/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Psychiatric disorders
Irritability
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Psychiatric disorders
Disorientation
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
10.0%
3/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Renal and urinary disorders
Dysuria
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
33.3%
1/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
6.7%
2/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
5.9%
1/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
5.3%
1/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Vascular disorders
Hypertension
|
11.8%
2/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
14.3%
1/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/17 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/19 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/8 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
3.3%
1/30 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
0.00%
0/3 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
28.6%
2/7 • From the time/date of initiation of study treatment through 30 days following cessation of study treatment and prior to initiation of other anticancer therapy, up to a maximum of 87.2 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 12 months of the completion of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given the opportunity to review and comment. Institution publications may be delayed up to an additional 90 days to allow the Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER